# China NMPA Product Recall - Fully automated urine analyzer; Automated urine analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-trading-china-co-ltd/85051ac8-e24f-4871-aa8a-749905a37366/
Source feed: China

> China NMPA product recall for Fully automated urine analyzer; Automated urine analyzer by Beckman Coulter Trading (China) Co., Ltd. published October 29, 2020. Recall level: Level 3. Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall of its fully automa

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter Trading (China) Co., Ltd. is voluntarily recalling its fully automated urine analyzer.
- Company Name: Beckman Coulter Trading (China) Co., Ltd.
- Publication Date: 2020-10-29
- Product Name: Fully automated urine analyzer; Automated urine analyzer
- Recall Level: Level 3
- Recall Reason: A manufacturing defect that could affect externally supplied SATA adapter cables
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter Trading (China) Co., Ltd.
- Summary: Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall of its fully automated urine analyzers, as announced by the National Medical Products Administration (NMPA) on October 29, 2020. This action, an update to an earlier March 2020 critical product notification, stems from the discovery of a manufacturing defect in a SATA adapter cable, which impacts the external power supply of the devices.

Initially, the issue was identified in instruments installed between July 2012 and December 2014. However, subsequent findings revealed that the defect extended beyond this initial scope, affecting additional units. The regulatory oversight for this recall falls under both the NMPA and the Shanghai Municipal Drug Administration.

As a required action, Beckman Coulter is actively informing customers about other instruments potentially impacted by this cable defect. The company is facilitating the recall process, with specific details regarding affected product models, specifications, and batches provided in an associated "Medical Device Recall Event Report Form." This proactive measure aims to address the identified product safety concern and ensure the integrity of their medical devices in the market.

Company: https://www.globalkeysolutions.net/companies/beckman-coulter-trading-china-co-ltd/ba5d4d83-dfa7-4af5-bc20-f9174025eaad/